FDA Grants Stent Indication of AMI
February 24, 2012 – The U.S. Food and Drug Administration (FDA) this week granted the first coronary stent indication for use in patients experiencing an acute myocardial infarction (AMI). The Boston Scientific Ion paclitaxel-eluting stent system and Taxus Liberte paclitaxel-eluting stent system are now the only drug-eluting stents (DES) in the United States with an approved indication to treat patients with AMI.
The new indication, which accounts for approximately 10 percent of all coronary interventions, is a result of FDA review of data from the paclitaxel (Taxus) clinical program and HORIZONS-AMI trial. In the global HORIZONS-AMI trial, 3,006 patients were randomized to receive either drug-eluting stents or bare-metal stents for the treatment of AMI, making it the largest randomized trial to study coronary stents in heart attack patients.
"The AMI indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced DES technologies," said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific. "Clinical data from the HORIZONS-AMI trial showed that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents, significantly reducing clinical and angiographic restenosis compared to bare-metal stents, while demonstrating a comparable safety profile at three years. We are proud that our investments in randomized trials such as HORIZONS-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease."
"The AMI indication reinforces the safety and effectiveness of the Ion and Taxus Liberte paclitaxel-eluting stents in treating challenging patients and lesions in both clinical and real-world practice,” said Hank Kucheman, CEO of Boston Scientific. “The inclusion of the Ion stent for this indication should be welcome news for physicians and patients. This innovative platinum chromium stent has been very well received since its U.S. launch last year based on its exceptional visibility, radial strength and deliverability."
The Ion stent incorporates a platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
For more information: www.bostonscientific.com
- The Boston Scientific Taxus Liberte.
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